A Phase 1 Open-Label Study of E7974 Administered on Days 1 and 15 of a 28-Day Cycle in Patients With Solid Malignancies

Trial Information

A Phase 1 Open-Label Study of E7974 Administered on Days 1 and 15 of a 28-Day Cycle in Patients With Solid Malignancies

Inclusion Criteria:

Patients who meet all of the inclusion criteria and none of the exclusion criteria will be
eligible for entry into the study:

1. Patients must have a pathologically diagnosed, histologically or cytologically
confirmed solid malignancy that has progressed following effective therapy or for
which no effective therapy exists (including surgery or radiation therapy).

2. Patients must be >= 18 years of age.

3. Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0, 1 or 2.

7. Patients must have adequate liver function as evidenced by bilirubin <= 1.5 mg/dL and
alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 times the
upper limits of normal (ULN), unless related to liver involvement by tumor, in which
case <= 5.0 times ULN.

8. Patients must be willing and able to sign written informed consent and be able to
comply with the study protocol for the duration of the study.

9. Patients must be willing and able to undergo blood draw and urine sampling for PK in
Cycle 1.

10. Patients may have either measurable or non-measurable disease.

For Prostate Cancer patients only being enrolled at the MTD expansion phase:

1. Males with histologically proven adenocarcinoma of the prostate that has progressed
(i.e. a minimum of three successive baseline values to document two consecutive rises
in Prostate Specific Antigen (PSA) (with the last value 5 ng/mL) taken at least one
week apart prior to study entry) despite castration or maintenance of castrate-level
testosterone (defined as serum testosterone 50 ng/dL or 1.7 nmol/L), during
non-hormonal chemotherapy.

2. Patients must have failed at least one previous chemotherapeutic regimen with tubulin
binding agents such as docetaxel.

Exclusion Criteria:The presence of one or more of the following criteria will disqualify a
patient from enrollment in the study:

1. Patients who have received chemotherapy within three weeks of E7974 treatment start
(6 weeks for a nitrosourea).

2. Patients who have not recovered from any chemotherapy-related or other
therapy-related toxicity to <= Grade 1 at study entry (excluding Grade 2 alopecia).

3. Patients who have received radiotherapy <= 3 weeks prior to study enrollment, whose
marrow exposure has exceeded 25% and who have not recovered from the toxic effects of
the treatment prior to study enrollment (except for alopecia).

4. Patients who have had major surgery without full recovery or major surgery within
three weeks of E7974 treatment start.

5. Patients with primary brain tumors or metastasis at study entry must have controlled
them for >= 1 month by previous treatment, including radiation therapy and
corticosteroids.

6. Women who are pregnant or breastfeeding.

7. Women of childbearing potential with either a positive serum pregnancy test at
screening or no pregnancy test.

13. Patients who have received organ allografts requiring immunosuppressive therapy.

14. Patients who have received investigational drugs including immunotherapy, gene
therapy, hormone therapy, biologic therapy, or chemotherapy within the three-week
period prior to E7974 treatment start; patients must have recovered from any previous
major therapy-related toxicities (Grade 3 or 4) to <= Grade 1 at study entry
(excluding Grade 2 alopecia).

15. Patients with a current history of peripheral neuropathy > CTC Grade 1 (e.g.,
diabetic or chemotherapy-induced neuropathy).

16. Patients with a history of uncontrolled seizures.

17. Patients with marked baseline prolongation of QT/QTc interval (QTc interval >470)
using the Fridericia method as the main method of QTc analysis.

18. Patients with other significant diseases or disorders that, in the Investigator's
opinion, would exclude them from the study.

19. Patients with allergy or hypersensitivity to hemiasterlin based product or analogue.

Type of Study:

Study Design:

Outcome Measure:

Determine the maximum tolerated dose of E7974 in patients with solid malignancies.

Outcome Time Frame:

Duration of each cycle will be 28 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study.

Safety Issue:

Yes

Principal Investigator

Naseem Zojwalla, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

E7974-A001-102

NCT ID:

NCT00130169

Start Date:

January 2006

Completion Date:

August 2009

Related Keywords:

Cancer, Malignant Tumors

Cancer

malignant tumors

Neoplasms

Name

Location

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